Diagnostics company ID-Fish Technology announced today that the US Food and Drug Administration (FDA) has cleared its new Lyme disease test.
The iDart Lyme IgG ImmunoBlot Kit is a stand-alone test for detecting Lyme-specific immunoglobulin G (IgG) antibodies that includes 31 Lyme antigen bands, more than any other Lyme test on the market. The company says the inclusion of 31 antigens will improve the sensitivity of Lyme disease diagnosis in suspected patients without sacrificing specificity.
"The R&D team at ID-FISH has worked tirelessly on making sure that we deliver the most accurate test possible for the detection of Lyme disease," ID-Fish Technology Chief Scientific Officer Jyotsna Shah, PhD, said in a company press release. "We look forward to working with partners to get these tests to patients who need a correct diagnosis."
Around 475,000 Americans annually are diagnosed with Lyme disease, which is caused by Borrelia burgdorferi, a type of bacteria carried by black-legged (deer) ticks.
Faster antimicrobial susceptibility test also cleared
In other diagnostic news, the Biomedical Advanced Research and Development Authority (BARDA) announced last week that the FDA has cleared bioMerieux's new antimicrobial susceptibility test (AST) for gram-negative pathogens commonly associated with bloodstream infections (BSIs).
The Vitek Reveal GN AST works with bioMerieux's Vitek Reveal AST System, which uses a metabolomic signature technology to produce phenotypic AST results from positive blood cultures within 5.5 to 6 hours—75% faster than traditional AST methods.
Fast and accurate AST results for gram-negative BSIs are considered crucial for reducing inappropriate antibiotic use and improving patient outcomes.
The test was developed by bioMerieux in partnership with BARDA.